NCT00209833

Brief Summary

This randomized phase II/III trial investigates the antileukemic activity and toxicity of the FLAG-Ida regimen as a second induction course in patients with acute myeloid leukaemia and bad response to the first induction cycle and/or with a high risk karyotype and compares the antileukemic activity and toxicity of high dose cytarabine/daunorubicin vs. autologous peripheral blood stem cell transplantation as late consolidation therapy in standard risk patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 1999

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
6.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

November 18, 2005

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

November 17, 2005

Conditions

De Novo Akute Myeloid Leukemia (AML)Secondary Acute Myeloid Leukemia (AML)Refractory Anemia With Excess of Blasts in Transformation

Outcome Measures

Primary Outcomes (2)

  • Efficacy and toxicity of FLAG-Ida as second induction course in high risk patients.

  • Efficacy and toxicity of high-dose cytarabin/daunorubicin (HD-Ara-C/DNR) based late consolidation therapy vs. autologous peripheral blood stem cell transplantation in standard risk patients.

Secondary Outcomes (2)

  • Monitoring residual disease (MRD) after induction, early and late consolidation by Real-time PCR.

  • Assessment of the prognostic relevance of minimal residual disease by quantification of minimal residual disease.

Interventions

CytarabineDRUG
IdarubicinDRUG
EtoposideDRUG
FludarabineDRUG
G-CSFDRUG
DaunorubicineDRUG

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • diagnosis of de-novo AML, FAB M 1, 2, 4 - 7
  • diagnosis of secondary AML after chemo-/radiotherapy or MDS
  • diagnosis of RAEB-T
  • age between 16 and 60 years (including 60 years)
  • written informed consent

You may not qualify if:

  • patients with severe disease of the heart (e.g. cardial failure NYHA III/IV; history of myocardial infarction within the last 6 months;severe ventricular arrythmias (Lown III to IV)
  • patients with DLCO \< 50%
  • patients with creatinine clearance \< 60 ml/min
  • patients with bilirubin \> 2mg% (34.2 mmol/L)
  • patients with severe complications of the leukaemia such as uncontrolled bleeding, pneumonia with hypoxia or shock
  • patients with a psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participating in this study
  • HIV positivity
  • patients with a t(15;17) translocation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, 30625, Germany

Location

Related Publications (6)

  • Thol F, Bollin R, Gehlhaar M, Walter C, Dugas M, Suchanek KJ, Kirchner A, Huang L, Chaturvedi A, Wichmann M, Wiehlmann L, Shahswar R, Damm F, Gohring G, Schlegelberger B, Schlenk R, Dohner K, Dohner H, Krauter J, Ganser A, Heuser M. Mutations in the cohesin complex in acute myeloid leukemia: clinical and prognostic implications. Blood. 2014 Feb 6;123(6):914-20. doi: 10.1182/blood-2013-07-518746. Epub 2013 Dec 13.

    PMID: 24335498DERIVED

  • Buchner T, Schlenk RF, Schaich M, Dohner K, Krahl R, Krauter J, Heil G, Krug U, Sauerland MC, Heinecke A, Spath D, Kramer M, Scholl S, Berdel WE, Hiddemann W, Hoelzer D, Hehlmann R, Hasford J, Hoffmann VS, Dohner H, Ehninger G, Ganser A, Niederwieser DW, Pfirrmann M. Acute Myeloid Leukemia (AML): different treatment strategies versus a common standard arm--combined prospective analysis by the German AML Intergroup. J Clin Oncol. 2012 Oct 10;30(29):3604-10. doi: 10.1200/JCO.2012.42.2907. Epub 2012 Sep 10.

    PMID: 22965967DERIVED

  • Thol F, Damm F, Ludeking A, Winschel C, Wagner K, Morgan M, Yun H, Gohring G, Schlegelberger B, Hoelzer D, Lubbert M, Kanz L, Fiedler W, Kirchner H, Heil G, Krauter J, Ganser A, Heuser M. Incidence and prognostic influence of DNMT3A mutations in acute myeloid leukemia. J Clin Oncol. 2011 Jul 20;29(21):2889-96. doi: 10.1200/JCO.2011.35.4894. Epub 2011 Jun 13.

    PMID: 21670448DERIVED

  • Damm F, Heuser M, Morgan M, Wagner K, Gorlich K, Grosshennig A, Hamwi I, Thol F, Surdziel E, Fiedler W, Lubbert M, Kanz L, Reuter C, Heil G, Delwel R, Lowenberg B, Valk PJ, Krauter J, Ganser A. Integrative prognostic risk score in acute myeloid leukemia with normal karyotype. Blood. 2011 Apr 28;117(17):4561-8. doi: 10.1182/blood-2010-08-303479. Epub 2011 Mar 3.

    PMID: 21372155DERIVED

  • Wagner K, Damm F, Thol F, Gohring G, Gorlich K, Heuser M, Schafer I, Schlegelberger B, Heil G, Ganser A, Krauter J. FLT3-internal tandem duplication and age are the major prognostic factors in patients with relapsed acute myeloid leukemia with normal karyotype. Haematologica. 2011 May;96(5):681-6. doi: 10.3324/haematol.2010.034074. Epub 2011 Jan 17.

    PMID: 21242187DERIVED

  • Thol F, Damm F, Wagner K, Gohring G, Schlegelberger B, Hoelzer D, Lubbert M, Heit W, Kanz L, Schlimok G, Raghavachar A, Fiedler W, Kirchner H, Heil G, Heuser M, Krauter J, Ganser A. Prognostic impact of IDH2 mutations in cytogenetically normal acute myeloid leukemia. Blood. 2010 Jul 29;116(4):614-6. doi: 10.1182/blood-2010-03-272146. Epub 2010 Apr 26.

    PMID: 20421455DERIVED

Related Links

MeSH Terms

Interventions

CytarabineIdarubicinEtoposidefludarabineGranulocyte Colony-Stimulating FactorDaunorubicin

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesColony-Stimulating FactorsGlycoproteinsGlycoconjugatesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Arnold Ganser, Prof. Dr.

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

January 1, 1999

Study Completion

September 1, 2005

Last Updated

November 18, 2005

Record last verified: 2005-09

Locations

DE(1)